Department of Neurology, Dell Medical School, University of Texas at Austin (S.J.W., A.N.D., T.J.M., S.M., N.D.Z., L.R.M., J.T.M., M.M., M.C.D., J.A.B., J.R.J., D.N.S., K.T.E., M.M.P., A.S.N., L.A.D., D.P.).
Ascension Healthcare, Austin, TX (S.J.W., T.J.M., S.M., L.A., C.M., C.A.J., L.R.M., J.T.M., M.M., M.C.D., J.A.B., A.Y.T., J.R.J., H.M.D., D.N.S., K.T.E., M.M.P., A.S.N., V.R.K.).
Stroke. 2022 Dec;53(12):3583-3593. doi: 10.1161/STROKEAHA.122.038950. Epub 2022 Sep 23.
A 10-hospital regional network transitioned to tenecteplase as the standard of care stroke thrombolytic in September 2019 because of potential workflow advantages and reported noninferior clinical outcomes relative to alteplase in meta-analyses of randomized trials. We assessed whether tenecteplase use in routine clinical practice reduced thrombolytic workflow times with noninferior clinical outcomes.
We designed a prospective registry-based observational, sequential cohort comparison of tenecteplase- (n=234) to alteplase-treated (n=354) stroke patients. We hypothesized: (1) an increase in the proportion of patients meeting target times for target door-to-needle time and transfer door-in-door-out time, and (2) noninferior favorable (discharge to home with independent ambulation) and unfavorable (symptomatic intracranial hemorrhage, in-hospital mortality or discharge to hospice) in the tenecteplase group. Total hospital cost associated with each treatment was also compared.
Target door-to-needle time within 45 minutes for all patients was superior for tenecteplase, 41% versus 29%; adjusted odds ratio, 1.85 (95% CI, 1.27-2.71); =0.001; 58% versus 41% by Get With The Guidelines criteria. Target door-in-door-out time within 90 minutes was superior for tenecteplase 37% (15/43) versus 14% (9/65); adjusted odds ratio, 3.62 (95% CI, 1.30-10.74); =0.02. Favorable outcome for tenecteplase fell within the 6.5% noninferiority margin; adjusted odds ratio, 1.26 (95% CI, 0.89-1.80). Unfavorable outcome was less for tenecteplase, 7.3% versus 11.9%, adjusted odds ratio, 0.77 (95% CI, 0.42-1.37) but did not fall within the prespecified 1% noninferior boundary. Net benefit (%favorable-%unfavorable) was greater for the tenecteplase sample: 37% versus 27%. =0.02. Median cost per hospital encounter was less for tenecteplase cases ($13 382 versus $15 841; <0.001).
Switching to tenecteplase in routine clinical practice in a 10-hospital network was associated with shorter door-to-needle time and door-in-door-out times, noninferior favorable clinical outcomes at discharge, and reduced hospital costs. Evaluation in larger, multicenter cohorts is recommended to determine if these observations generalize.
由于潜在的工作流程优势以及荟萃分析中报告的与阿替普酶相比非劣效的临床结局，2019 年 9 月，一个由 10 家医院组成的区域网络过渡到使用替奈普酶作为标准的卒中溶栓治疗。我们评估了在常规临床实践中使用替奈普酶是否可以缩短溶栓工作流程时间，同时保持非劣效的临床结局。
我们设计了一项前瞻性基于登记的观察性、连续队列比较研究，比较了替奈普酶治疗（n=234）和阿替普酶治疗（n=354）的卒中患者。我们假设：（1）符合目标门到针时间和转移门到门时间的患者比例增加，（2）替奈普酶组的有利结局（出院回家独立行走）和不利结局（症状性颅内出血、住院死亡率或出院到临终关怀）非劣效。还比较了两种治疗方法的总医院成本。
所有患者在 45 分钟内达到目标门到针时间的比例替奈普酶组更优，为 41%，阿替普酶组为 29%；调整后的优势比为 1.85（95%可信区间，1.27-2.71）；P=0.001；符合 Get With The Guidelines 标准的患者中，替奈普酶组为 58%，阿替普酶组为 41%。在 90 分钟内达到目标门到门时间的比例替奈普酶组更优，为 37%（15/43），阿替普酶组为 14%（9/65）；调整后的优势比为 3.62（95%可信区间，1.30-10.74）；P=0.02。替奈普酶组的有利结局在 6.5%的非劣效性边界内；调整后的优势比为 1.26（95%可信区间，0.89-1.80）。替奈普酶组的不利结局更少，为 7.3%，阿替普酶组为 11.9%，调整后的优势比为 0.77（95%可信区间，0.42-1.37），但不在预先指定的 1%非劣效性边界内。替奈普酶组的净效益（%有利-%不利）更高，为 37%；P=0.02。替奈普酶组的每例住院费用中位数更低，为$13382，阿替普酶组为$15841；P<0.001）。
在一个由 10 家医院组成的网络中，常规临床实践中转换为使用替奈普酶与更短的门到针时间和门到门时间有关，出院时的有利临床结局非劣效，并且降低了医院成本。建议在更大的多中心队列中进行评估，以确定这些观察结果是否具有普遍性。
